Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 968-969 [07-28]
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968
Federal Register / Vol. 72, No. 5 / Tuesday, January 9, 2007 / Notices
receives on the docket (Docket Number
2006D–0347). Suggestions,
recommendations, and materials may be
seen at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
V. Transcripts
Following the meeting, transcripts
will be available for review at https://
www.fda.gov/cdrh/oivd/
presentations.html#r, and the Division
of Dockets Management (see ADDRESSES)
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: January 3, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07–93 Filed 1–8–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Medical Devices 101: An Educational
Forum; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ycherry on PROD1PC63 with NOTICES
ACTION:
Notice of public workshop.
SUMMARY: The Food and Drug
Administration (FDA), Office of
Regulatory Affairs (ORA), Southwest
Regional Office (SWRO), in
cosponsorship with the FDA Medical
Device Industry Coalition (FMDIC) and
the Risk Management Small Business
Development Center (RMSBDC), is
announcing a public workshop entitled
‘‘Medical Devices 101: An Educational
Forum.’’ This public workshop is
intended to provide an overview on
FDA’s medical device requirements to
entrepreneurs, startup companies, and
small businesses.
Date and Time: The public workshop
will be held on February 9, 2007, from
8 a.m. to 5 p.m.
Location: The public workshop will
be held at the Hoblitzelle Auditorium at
the Bill Priest Campus of El Centro
College, 1402 Corinth St. in Dallas, TX.
Contact Person: David Arvelo, Food
and Drug Administration, 4040 North
Central Expressway, suite 900, Dallas,
TX 75204, 214–253–4952, FAX: 214–
253–4970, e-mail:
oraswrsbr@fda.hhs.gov.
Registration: Registration by January
26, 2007, is strongly encouraged. The
RMSBDC has a $75 early registration fee
to cover the cost of facilities, materials,
and refreshments. Please submit your
registration as soon as possible.
Registration at the site may be possible
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13:55 Jan 08, 2007
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on a space available basis on the day of
the public workshop beginning at 8 a.m.
The cost of registration after January 26,
2007, is $99 payable to RMSBDC. If you
need special accommodations due to a
disability, please contact David Arvelo
(see Contact Person) at least 7 days in
advance.
Registration Form Instructions: To
register, please complete the RMSBDC
registration form and submit along with
payment to RMSBDC, Attn: Saira
Roberts, 1402 Corinth St., Dallas, TX
75215. You may fax the completed
registration form to RMSBDC at 214–
860–5867. To obtain a copy of the
registration form, please call RMSBDC
at 214–860–5887 or 214–860–5849. The
registration form is also available online
at https://www.ntsbdc.org/.
Transcripts: Transcripts of the public
workshop will not be available due to
the format of this workshop. Course
handouts may be requested in writing
from the Freedom of Information Office
(HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857,
approximately 15 working days after the
public workshop at a cost of 10 cents
per page.
SUPPLEMENTARY INFORMATION: The
workshop is being held in response to
the interest in the topics discussed from
small medical device entrepreneurs and
startup manufacturers in the Dallas
District area. FDA presents this
workshop in cosponsorship with FMDIC
and RMSBDC to help achieve objectives
set forth in section 406 of the Food and
Drug Administration Modernization Act
of 1997 (21 U.S.C. 393), which include
working closely with stakeholders and
maximizing the availability and clarity
of information to stakeholders and the
public. This is also consistent with the
purposes of FDA’s Regional Small
Business Program, which are in part to
respond to industry inquiries, develop
educational materials, sponsor
workshops and conferences to provide
firms, particularly small businesses,
with firsthand working knowledge of
FDA’s requirements and compliance
policies. This workshop is also
consistent with the Small Business
Regulatory Enforcement Fairness Act of
1996 (Public Law 104–121), as an
outreach activity by Government
agencies to small businesses.
The goal of the workshop is to present
information that will enable
manufacturers and regulated industry to
better comply with the Medical Device
QSR. The following topics will be
broadly covered at the workshop: (1)
Medical device classification, (2)
establishment registration, (3) device
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listing, (4) premarket notification, (5)
premarket approval, (6) Quality System
Regulation, (7) labeling, and (8)
postmarket surveillance.
Dated: January 3, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07–92 Filed 1–8–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committee: Vaccines and
Related Biological Products Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on January 25, 2007, from 8 a.m.
to 5 p.m.
Location: Doubletree Hotel, 8120
Wisconsin Ave., Bethesda, MD 20814.
Contact Person: Christine Walsh or
Denise Royster, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852,
301–827–0314, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512391. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: In Session I, the committee
will hear presentations and make
recommendations on the safety and
immunogenicity of PENTACEL
(Diphtheria and Tetanus Toxoids and
Acellular Pertussis Adsorbed,
Inactivated Poliovirus and Haemophilus
b Conjugate (Tetanus Toxoid Conjugate)
Vaccine Combined (DTaP-IPV/Hib)),
manufactured by Sanofi Pasteur, Ltd. In
Session II, the committee will hear an
overview of the research programs in
the Office of Vaccines Research and
Review, Center for Biologics Evaluation
and Research (CBER). In the closed
session, the committee will discuss the
E:\FR\FM\09JAN1.SGM
09JAN1
969
Federal Register / Vol. 72, No. 5 / Tuesday, January 9, 2007 / Notices
report of the Office of Vaccines Research
and Review Office Site Visit of May 19,
2006.
FDA intends to make background
material available to the public no later
than 1 business day before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm. Click on the
year 2007 and scroll down to the
appropriate advisory committee link.
Procedure: On January 25, 2007, from
8 a.m. to 4:25 p.m., the meeting is open
to the public. Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before January 19, 2007.
Oral presentations from the public will
be scheduled between approximately
11:15 a.m. to 11:45 a.m. and 3:55 p.m.
to 4:25 p.m. Those desiring to make
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before January 11, 2007. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
January 12, 2007.
Closed Committee Deliberations: On
January 25, 2007, from 4:25 p.m. to 5
p.m., the meeting will be closed to
permit discussion where disclosure
would constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C.
552b(c)(6)). The committee will discuss
the report of the May 19, 2006, review
of internal research programs in the
Office of Vaccines Research and Review,
Division of Viral Products and Division
of Bacterial, Parasitic, and Allergenic
Products, CBER.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Christine
Walsh or Denise Royster at least 7 days
in advance of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: January 3, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. 07–28 Filed 1–4–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, call the HRSA Reports
Clearance Office on (301) 443–1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: The Health Education
Assistance Loan (HEAL) Program
Regulations (OMB No. 0915–0108):
Extension
The Health Education Assistance
Loan (HEAL) Program has regulations
that contain notification, reporting and
recordkeeping requirements to insure
that the lenders, holders and schools
participating in the HEAL program
follow sound management procedures
in the administration of federallyinsured student loans. While the
regulatory requirements are approved
under the OMB number referenced
above, much of the burden associated
with the regulations is cleared under the
OMB numbers for the HEAL forms and
electronic submissions used to report
required information. The table listed at
the end of this notice contains the
estimate of burden for the remaining
regulations.
The estimates of burden are as
follows:
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
Number of
respondents
Number of transactions
Hours per
response
(minutes)
Total
transactions
Total burden
hours
Reporting Requirements
17 Holders .............................................................................................
190 Schools ...........................................................................................
Total Reporting ...............................................................................
5
.4
............................
78
76
12
10
17
13
..........................
..........................
30
ycherry on PROD1PC63 with NOTICES
Notification Requirements
7,930 Borrowers ....................................................................................
17 Holders .............................................................................................
190 Schools ...........................................................................................
1
7,910
.89
7,930
134,470
170
10
10
14
1,322
22,412
40
Total Notification .............................................................................
............................
..........................
..........................
23,774
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09JAN1
]]>Agencies
[Federal Register Volume 72, Number 5 (Tuesday, January 9, 2007)]
[Notices]
[Pages 968-969]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-28]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). At least one
portion of the meeting will be closed to the public.
Name of Committee: Vaccines and Related Biological Products
Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on January 25, 2007, from 8
a.m. to 5 p.m.
Location: Doubletree Hotel, 8120 Wisconsin Ave., Bethesda, MD
20814.
Contact Person: Christine Walsh or Denise Royster, Center for
Biologics Evaluation and Research (HFM-71), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 3014512391. Please call the
Information Line for up-to-date information on this meeting.
Agenda: In Session I, the committee will hear presentations and
make recommendations on the safety and immunogenicity of PENTACEL
(Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed,
Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid
Conjugate) Vaccine Combined (DTaP-IPV/Hib)), manufactured by Sanofi
Pasteur, Ltd. In Session II, the committee will hear an overview of the
research programs in the Office of Vaccines Research and Review, Center
for Biologics Evaluation and Research (CBER). In the closed session,
the committee will discuss the
[[Page 969]]
report of the Office of Vaccines Research and Review Office Site Visit
of May 19, 2006.
FDA intends to make background material available to the public no
later than 1 business day before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/ohrms/dockets/ac/
acmenu.htm. Click on the year 2007 and scroll down to the
appropriate advisory committee link.
Procedure: On January 25, 2007, from 8 a.m. to 4:25 p.m., the
meeting is open to the public. Interested persons may present data,
information, or views, orally or in writing, on issues pending before
the committee. Written submissions may be made to the contact person on
or before January 19, 2007. Oral presentations from the public will be
scheduled between approximately 11:15 a.m. to 11:45 a.m. and 3:55 p.m.
to 4:25 p.m. Those desiring to make formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
January 11, 2007. Time allotted for each presentation may be limited.
If the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by January 12,
2007.
Closed Committee Deliberations: On January 25, 2007, from 4:25 p.m.
to 5 p.m., the meeting will be closed to permit discussion where
disclosure would constitute a clearly unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). The committee will discuss the report of
the May 19, 2006, review of internal research programs in the Office of
Vaccines Research and Review, Division of Viral Products and Division
of Bacterial, Parasitic, and Allergenic Products, CBER.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Christine Walsh or
Denise Royster at least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: January 3, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. 07-28 Filed 1-4-07; 8:45 am]
BILLING CODE 4160-01-S
